Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder
NCT ID: NCT06384157
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2024-06-10
2025-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets
INDV-2000
INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.
200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets
INDV-2000
INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.
400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets
INDV-2000
INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.
Placebo dose
Placebo
This is a randomized, double-blind, placebo-controlled study.
Interventions
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INDV-2000
INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.
Placebo
This is a randomized, double-blind, placebo-controlled study.
Eligibility Criteria
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Inclusion Criteria
1. Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place to 65 years of age inclusive, at the time of signing the informed consent.
2. Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
3. Males or females with moderate or severe opioid use disorder (OUD) by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who are looking to transition from daily short-term opioid agonist treatment (medically supervised withdrawal) to non-opioid treatment.
4. Have not been on medication for opioid use for 3 months prior to the current treatment episode, and satisfies either a or b below.
1. The participant will initiate, or is undergoing medically supervised withdrawal, and
* In the opinion of the investigator, the participant is able to achieve a stable dose of transmucosal (TM) buprenorphine between ≤24 mg inclusive prior to randomization.
* Current opioid agonist treatment does not exceed 35 days from the start of TM buprenorphine to the end of Screening window.
2. The participant recently completed medically supervised withdrawal outside of the study, and
* Time elapsed between last dose of TM buprenorphine or other withdrawal medication and Study Day 1/randomization does not exceed 21 calendar days.
* Recently completed opioid agonist treatment does not exceed 35 days of TM buprenorphine dosing days inclusive of medically assisted withdrawal dosing.
5. Male participants who are sexually active with individuals who are of childbearing potential must agree to use a medically acceptable forms of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: established use of oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide), or abstinence.
6. A female participant of non-childbearing potential, or a male of childbearing potential if
* She agrees to use a medically acceptable form of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: abstinence; established use or oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide).
* She is not pregnant as confirmed by a negative serum screening and or urine human chorionic gonadotrophin test on Study Day 1.
* She is not lactating.
7. Body mass index (BMI) within 18.0 to 40.0 kg/m2 (inclusive)
Exclusion Criteria
1. Have a current diagnosis, other than OUD, requiring chronic opioid treatment.
2. Have a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
3. Meet DSM-5 criteria for severe substance use disorder other than opioids.
4. Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder that would impact participation in the study as judged by an Investigator or medically responsible physician.
5. Had an opioid overdose event within the 6 months prior to the Screening Visit.
6. Uses any substance of abuse via the injection route more than 2 times per week over the last 3 months prior to Screening.
7. Have clinically significant abnormal biochemistry, hematology or urinalysis results that would impact participation in the study as judged by an Investigator or medically responsible physician.
8. Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
9. Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
10. History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.
11. Serious cardiac illness or other cardiac assessments including, but not limited to:
* Uncontrolled arrhythmias.
* History of congestive heart failure.
* Myocardial infarction \<6 months from receipt of first dose of investigational medicinal product (IMP)
* Uncontrolled symptomatic angina
* QT interval corrected with Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females or history of prolonged QT syndrome.
12. Have any combination of the following at screening:
* Total bilirubin ≥1.5×upper limit of normal (ULN) (with direct bilirubin \>1.3 mg/dL),
* Alanine aminotransferase (ALT) ≥3×ULN
* Aspartate aminotransferase (AST) ≥3×ULN
* International normalized ratio (INR) \>1.2 for participants not receiving anticoagulation therapy, \>3.0 for participants on conventional coagulation therapy, \>3.5 for participants on intensive anticoagulation, or
* Estimated glomerular filtration rate \<60 mL/min by Cockroft-Gault formula.
13. Current symptomatic hepatic or biliary disease, including participants with cholecystectomy \<90 days prior to Screening.
14. Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively.
15. Concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to the signing the informed consent form.
16. Blood or platelets donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (\<11 g/dL for females, \<12 g/dL for males).
17. Known allergy or hypersensitivity to IMP or its excipients.
18. Any condition that, in the opinion of an Investigator or medically responsible physician, would interfere with evaluation of the IMP or interpretation of participant safety or study results.
19. Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff, Indivior, or Clinical Research Organization \[CRO\] employee).
20. Participants who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements, including prohibited concomitant therapies.
21. Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.
18 Years
65 Years
ALL
No
Sponsors
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Indivior Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Director Clinical Development
Role: STUDY_DIRECTOR
Indivior Inc.
Locations
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Boyett Health Services Inc
Hamilton, Alabama, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
North County Clinical Research
Oceanside, California, United States
Empire Clinical Research
Pomona, California, United States
Artemis Institute For Clinical Research - San Diego
San Diego, California, United States
Imagine Research of Palm Beach County
Boynton Beach, Florida, United States
Bold City Clinical Research
Jacksonville, Florida, United States
Vitalix Kissimmee
Kissimmee, Florida, United States
Accel Research Sites - Lakeland
Lakeland, Florida, United States
Quantum Clinical Trials
Miami Beach, Florida, United States
Segal Trials Miami Lakes
Miami Lakes, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Agile Clinical Research Trials
Atlanta, Georgia, United States
Maryland Treatment Centers
Baltimore, Maryland, United States
Vitalix Clinical
Worcester, Massachusetts, United States
Insight Research Institute
Flint, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
Arch Clinical Trials
St Louis, Missouri, United States
IMA Clinical Research
Las Vegas, Nevada, United States
Oasis Clinical Research
Las Vegas, Nevada, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Dr Vando Medical Services
The Bronx, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
West Clinical Research
Morehead City, North Carolina, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
Pahl Pharmaceutical Professionals, LLC
Oklahoma City, Oklahoma, United States
SP Research PLLC Rivus Wellness and Research Insitute
Oklahoma City, Oklahoma, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Prisma Health Addiction Medicine Center
Greenville, South Carolina, United States
Insite Clinical Research, LLC
DeSoto, Texas, United States
El Paso Clinical Trials
El Paso, Texas, United States
HD Research
Houston, Texas, United States
Progressive Clinical Research Llc
Bountiful, Utah, United States
Alpine Research Organisation
Clinton, Utah, United States
Boeson Clinical Research
Provo, Utah, United States
Countries
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Other Identifiers
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INDV-2000-201
Identifier Type: -
Identifier Source: org_study_id